CLASS II Device recall · Reported 28 May 2014 · FDA Enforcement Report
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable recalled
Arrow International is recalling Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a, distributed in Michigan. The recall was initiated on 17 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1633-2014
- FDA event ID
- 67833
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2013
- FDA classified
- 19 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Jul 2013 | Recall initiated by company | |
| 19 May 2014 | Classified by FDA | +306 days |
| 28 May 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r
Product as listed by the FDA
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Where it was distributed
US Distribution only to MI.
Questions about this recall
Is Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a recalled?
Yes. Arrow International recalled Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a on 17 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1633-2014.
Why was it recalled?
The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r
Which lots are affected?
MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733
Where was it sold?
US Distribution only to MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |